USOO7651705B2

(12) United States Patent (10) Patent No.: US 7.651,705 B2 Rao et al. (45) Date of Patent: Jan. 26, 2010

(54) HERBAL COMPOSITION FOR THE Dehpour, A. R. et al. International Journal of Pharmaceutics (1995), TREATMENT OF GASTRICULCER 119(2): 133-138. Antiulcer activities of liquorice and its derivatives in experimental gastric lesion induced by ibuprofen in rats. (75) Inventors: Janaswamy Madhusudana Rao, Johnson, T. CRC Ethnobotany Desk Reference (1999), CRC Press Hyderabad Andhra Pradesh (IN); LLC, Boca Raton, Florida, p. 842, 26 1911.* Upparapalli Sampathkumar, Goel, R. L. et al. Journal of Ethanopharmacology (1986), 18(1): Hyderabad Andhra Pradesh (IN); 33-44. Anti-ulcerogenic effect of bananan powder Musa Boggavarapu Subrahmanya Sastry, sapeientum-var-paradisiaca and its effect on mucosal resistance. Hyderabad Andhra Pradesh (IN); Jhillu Khrenova, D. et al. Farmatsiya (1986), 35(3): 46-48. Qualitative Singh Yadav, Hyderabad Andhra phytochemical analysis of an antiulcerous drugs prepared from Pradesh (IN); Kondapuram Vijaya plants.* Raghavan, Hyderabad Andhra Pradesh http://www.henriettesherbal.com/eclectic/usdisp? ferula-aSaf.html. (JP); Gautam Palit, Lucknow (IN); Remington, et al. The Dispensatory of the United States of America. Dwaraka Nath Bhalla, Lucknow (IN); Downloaded Jan. 21, 2007.* Deepak Rai, Lucknow (IN); U1, Khrenova, D. etal. Farmatsiya (1986), 35(3): 46-48. Qualitative Panniyampally Madhavankutty phytochemical analysis of an antiulcerous drugs prepared from Varier, Kerala (IN); Trikovil Sankaran plants.* Christina, A.J.M. et al. Methods Find Exp Clin Pharmacol (Mar. Muraleedharan, Kerala (IN); Kollath 2002), 24(2): 77-79. Modulatory effet of Cyclea peltata Lam. on Muraleedharan, Kerala (IN) Stone formation induced by ethylene glycol treatment in rats. Lewis, D. A. et al. J of Ethnopharmacology (1999), 6.5: 283-288. A (73) Assignee: Council of Scientific & Industrial natural flavonoid present in unripe plantain banana pulp (Musa Research, New Delhi (IN) sapientum L. var. paradisiaca) protects the gastric mucosa from (*) Notice: Subject to any disclaimer, the term of this aspirin-induced erosions. Rao, I. G. et al., Chemophere (Sep. 2001), 44(8): 1691-1695. Com patent is extended or adjusted under 35 binations of Azadirachta indica and Cedrus deodara oil with U.S.C. 154(b) by 25 days. piperonyl butoxide, MGK-264 and Embelia ribes against Lymnaea acuminata. (21) Appl. No.: 10/695,471 Singh, A. etal. Indian Journal of Experimental Biology (2001),39(3): 263-268. Molluscicidal activity of Lawsonia inermis and its binary (22) Filed: Oct. 28, 2003 and tertiary combinations with other plant derived molluscicides. Abstract. (65) Prior Publication Data Rao, V. L. N., et al. Indian Pharmacist (1948), 4: 14-17 and 32. US 2005/OO89583 A1 Apr. 28, 2005 Pharmacognosy of Carum roxburghianum Benth.* Hankey, W. F. Am. Drug (1907), 49: 360-362. The assay processes of (51) Int. Cl. the U. S. Pharmacopoeia, VIII. Abstract.* AOIN 65/00 (2006.01) Purohit, M. G. et al. Indian Journal of Pharmaceutical Science A6 IK 36/8965 (2006.01) (1996), 58(3): 110-112. Antiulcer and anticatatonic activity of alco A6 IK 36/484 (2006.01) holic extract of Evolvulus alsinoides.).* (52) U.S. Cl...... 424/725; 424/757: 514/924 PK. Warrier, Indian Medicinal Plants—A compendium of 500 spe (58) Field of Classification Search ...... 424/744, cies (1994-1996) vol. 1, p. 218-219, published by orient Longman, 424/757, 725; 514/925, 783 Chennai. See application file for complete search history. (Continued) (56) References Cited Primary Examiner Michele Flood U.S. PATENT DOCUMENTS (74) Attorney, Agent, or Firm John P. White; Cooper & Dunham LLP 2,704,258 A * 3/1955 Haney 4,022.921 A * 5/1977 Sakakibara et al. (57) ABSTRACT 4,544.551 A * 10/1985 Hong-Yue 4,851.224 A * 7/1989 McAnalley 4,913,909 A * 4/1990 Hara et al. Provided herein are synergistic herbal compositions for the 7,025,995 B2 * 4/2006 Palpu et al. treatment of gastric ulcer, said composition essentially com prising powdered plant parts of Asparagus racemosus, Gly FOREIGN PATENT DOCUMENTS cyrrhiza glabra, Sesamum indicum, Musa sapientum and Trachyspermum roxburghianum and optionally, powdered CN 1129570 A * 8, 1996 plant parts of Cyclea peltata, Embelia ribes, Coriandrum JP 54O67038 A * 5, 1979 sativum Ferulaasafetida, Aloe barbadensis and Evolvulus aisinodes along with one or more pharmaceutically accept OTHER PUBLICATIONS able additives/carriers, processes for preparing Such compo sitions and methods for treating gastric ulcers using Such Goel, R. K. etal. Indian Journal of Pharmacology (Jul. 2002), 34(2): compositions. 100-110. Anti-ulcer drugs from indigenous sources with emphasis on Musa sapientum, Tamrabhasma, Asparagus racemosus and Zingiber officinale.* 8 Claims, No Drawings US 7.651,705 B2 Page 2

OTHER PUBLICATIONS PK. Warrier, Indian Medicinal Plants—A compendium of 500 spe cies (1994-1996) vol. 3, p. 13-16, published by orient Longman, PK. Warrier, Indian Medicinal Plants—A compendium of 500 spe Chennai. cies (1994-1996) vol. 3, p. 86-87, published by orient Longman, K.M. Nadkarni, Indian Materia Medica (1976) vol. 1, pp. 74-76, Chennai. published by Popular Prakashan Pvt. Ltd., Mumbai. PK. Warrier, Indian Medicinal Plants—A compendium of 500 spe K.M. Nadkarni, Indian Materia Medica (1976) vol. 1, p. 582, pub cies (1994-1996) vol. 3, pp. 11-12, published by orient Longman, lished by Popular Prakashan Pvt. Ltd., Mumbai. Chennai. K.M. Nadkarni, Indian Materia Medica (1976) vol. 1. pp. 1027-1028, PK. Warrier, Indian Medicinal Plants—A compendium of 500 spe published by Popular Prakashan Pvt. Ltd, Mumbai. cies (1994-1996) vol. 4, p. 78, published by orient Longman, Chen K.M. Nadkarni, Indian Materia Medica (1976) vol. 1, p. 531, pub a. lished by Popular Prakashan Pvt. Ltd., Mumbai. PK. Warrier, Indian Medicinal Plants—A compendium of 500 spe K.M. Nadkarni, Indian Materia Medica (1976) vol. 1, pp. 822-825, cies (1994-1996) vol. 3, p. 297-299, published by orient Longman, published by Popular Prakashan Pvt. Ltd., Mumbai. Chennai. K.M. Nadkarni, Indian Materia Medica (1976) vol. 1. pp. 1028-1030, PK. Warrier, Indian Medicinal Plants—A compendium of 500 spe published by Popular Prakashan Pvt. Ltd., Mumbai. cies (1994-1996) vol. 2, p. 368-369, published by orient Longman, K.M. Nadkarni, Indian Materia Medica (1976) vol. 1, p. 478, pub Chennai. lished by Popular Prakashan Pvt. Ltd., Mumbai. PK. Warrier in Indian Medicinal Plants—A compendium of 500 K.M. Nadkarni, Indian Mateira Medica (1976) vol. 1, pp. 381-382, species (1994-1996) vol. 2, p. 184-185, published by orient Long published by Popular Prakashan Pvt. Ltd., Mumbai. man, Chennai. K.M. Nadkarni in Indian Materia Medica (1976) vol. 1, p. 537, PK. Warrier, Indian Medicinal Plants—A compendium of 500 spe published by Popular Prakashan Pvt. Ltd., Mumbai. cies (1994-1996) vol. 2, p. 277-278, published by orient Longman, Chennai. * cited by examiner US 7,651,705 B2 1. 2 HERBAL COMPOSITION FOR THE by Bishen Singh Mahendrapal Singh, Dehradun; P. K. War TREATMENT OF GASTRICULCER rier in Indian Medicinal Plants- A compendium of 500 spe cies (1994-1996) Vol. 5, p. 104, and The Wealth of India FIELD OF THE INVENTION (1950-1980) Vol.9, p. 290, published by Council of Scientific and Industrial Research for the various medicinal properties The present invention relates to a synergistic herbal com of Sesamum indicum. position for the treatment of gastric ulcer. The present inven References may be made to K. M. Nadkarni in Indian tion also relates to a method for the preparation of the com Materia Medica (1976) Vol. 1, p 531, published by Popular position. The present invention further relates to a process for Prakashan Pvt. Ltd., Mumbai, P. K. Warrier in Indian Medici the treatment of gastric ulcer using the composition. 10 nal Plants- A compendium of 500 species (1994-1996) Vol. 3, p. 11-12, and K. Narayana Iyer and M. Kolammal in Phar BACKGROUND AND PRIOR ART TO THE macognosy of Ayurvedic Drugs (1963) Series 1, No. 6, p. 1, INVENTION published by Department of Pharmacognosy, University of Kerala, Trivandrum for the various medicinal properties of Various theories have been proposed with respect to a 15 Evolvulus alsinoides. cause of ulcer in human. In particular, it has been elucidated References may be made to K. M. Nadkarni in Indian that stress, taking of non-steroidal anti-inflammatory drugs Materia Medica (1976) Vol. 1, p822-825, published by Popu for curing rheumatic diseases, and the like are closely related lar Prakashan Pvt. Ltd., Mumbai; K. R. Kirtikar in Indian to ulcer formation, mainly due to relatively excess gastric or Medicinal Plants (1975) Vol. 4, p. 2454, published by Bishen duodenal acid secretion. Accordingly it is important to Sup Singh Mahendrapal Singh, Dehradun, and P. K. Warrier in press the acid secretion in order to prevent ulcer formation Indian Medicinal Plants- A compendium of 500 species and to cure it. (1994-1996) Vol. 4, p. 78 for the various medicinal properties On the other hand it has been considered that Helicobacter of Musa sapientum. pylori, which is a rod normally existing in stomach, generates References may be made to K. M. Nadkarni in Indian ammonia due to its strong urease activity, thereby inducing 25 Materia Medica (1976) Vol. 1, p 1028-1030, published by ulcer. Since, it persistently lives within mucus and mucosa, it Popular Prakashan Pvt. Ltd., Mumbai; P. K. Warrier in Indian becomes the greatest cause for recurrence of ulcer. Accord Medicinal Plants-A compendium of 500 species (1994-1996) ingly, it has been considered that the recurrence of ulcer can Vol. 3, p. 299, published by orient Longman, Chennai; The be prevented, if this bacterium is sterilized. Wealth of India (1950-1980) Vol. 10, p. 271, published by References may be made to K. M. Nadkarni in Indian 30 Council of Scientific and Industrial Research; Y. K. Sarin in Materia Medica (1976) Vol. 1, p 74-76, 155, published by Illustrated lanual of herbal drugs used in Ayurveda (1996), p. Popular Prakashan Pvt. Ltd., Mumbai; K. R. Kirtikar in 202, and The Ayurvedic Pharmacopoeia of India, Vol. 1, p. 3, Indian Medicinal Plants (1975) Vol. 4, p 2505 published by published by Ministry of Health and Family Welfare, India Bishen Singh Mahendrapal Singh, Dehradun and P. K. War for the various medicinal properties of Trachyspermum rox rier in Indian Medicinal Plants- A compendium of 500 spe 35 burghianum. cies (1994-1996) Vol. 1, p 103 for the various medicinal References may be made to K. M. Nadkarni in Indian properties of Aloe barbadensis. Materia Medica (1976) Vol. 1, p. 478, published by Popular References may be made to K. M. Nadkarni in Indian Prakashan Pvt. Ltd., Mumbai; K. R. Kirtikar in Indian Materia Medica (1976) Vol. 1, p 155 published by Popular Medicinal Plants (1975) Vol. 2, p. 1479, published by Bishen Prakashan Pvt. Ltd., Mumbai; K. R. Kirtikar in Indian 40 Singh Mahendrapal Singh, Dehradun; P. K. Warrier in Indian Medicinal Plants (1975) Vol. 4, p 2249 published by Bishen Medicinal Plants-A compendium of 500 species (1994-1996) Singh Mahendrapal Singh, Dehradun; P. K. Warrier in Indian Vol. 2, p. 368, published by orient Longman, Chennai; The Medicinal Plants-A compendium of 500 species (1994-1996) Wealth of India (1950-1980) Vol. 3, p. 167, published by Vol. 1, p 218, and K. Narayana Iyer and M. Kolammal in Council of Scientific and Industrial Research; Y. K. Sarin in Pharmacognosy of Ayurvedic Drugs (1963) Series 1, No. 6, p. 45 Illustrated lanual of herbal drugs used in Ayurveda (1996), p. 48 published by Department of Pharmacognosy, University 290, and The Ayurvedic Pharmacopoeia of India, Vol. 1, p. of Kerala, Trivandrum for the various medicinal properties of 124, published by Ministry of Health and Family Welfare, Asparagus racemosus. India for the various medicinal properties of Embelia ribes. References may be made to K. M. Nadkarni in Indian References may be made to K. M. Nadkarni in Indian Materia Medica (1976) Vol. 1, p 582 published by Popular 50 Materia Medica (1976) Vol. 1, p. 381-82, published by Popu Prakashan Pvt. Ltd., Mumbai; K. R. Kirtikar in Indian lar Prakashan Pvt. Ltd., Mumbai; K. R. Kirtikar in Indian Medicinal Plants (1975) Vol. 1, p. 728 published by Bishen Medicinal Plants (1975) Vol. 2, p. 1225, published by Bishen Singh Mahendrapal Singh, Dehradun; P. K. Warrier in Indian Singh Mahendrapal Singh, Dehradun; P. K. Warrier in Indian Medicinal Plants-A compendium of 500 species (1994-1996) Medicinal Plants-A compendium of 500 species (1994-1996) Vol. 3, p. 84, 86-87: The Wealth of India (1950-1980) Vol. 4, 55 Vol. 2, p. 184, published by orient Longman, Chennai, and p. 152-153, published by Council of Scientific and Industrial The Wealth of India (1950-1980) Vol. 3, p. 349, published by Research: S.S. Handa in Indian Herbal Pharmacopeia (1998), Council of Scientific and Industrial Research for the various p. 96, published by Regional Research Laboratory, Jammu medicinal properties of Coriandrum sativum. and IDMA, Mumbai;Y.K. Sarin in Illustratedlanual of herbal Reference may be made to P. K. Warrier in Indian Medici drugs used in Ayurveda (1996), p. 116, and The Ayurvedic 60 nal Plants- A compendium of 500 species (1994-1996) Vol. 2, Pharmacopoeia of India, Vol. 1, p. 128, published by Ministry p. 277, published by orient Longman for the various medici of Health and Family Welfare, India for the various medicinal nal properties of Cyclea peltata. properties of Glycyrrhiza glabra. References may be made to K. M. Nadkarni in Indian References may be made to K. M. Nadkarni in Indian Materia Medica (1976) Vol. 1, p. 537, published by Popular Materia Medica (1976) Vol. 1, p. 1127-28, published by 65 Prakashan Pvt. Ltd., Mumbai; K. R. Kirtikar in Indian Popular Prakashan Pvt. Ltd., Mumbai; K. R. Kirtikar in Medicinal Plants (1975) Vol. 2, p. 1217, published by Bishen Indian Medicinal Plants (1975) Vol. 3, p. 1858-89 published Singh Mahendrapal Singh, Dehradun; P. K. Warrier in Indian US 7,651,705 B2 3 4 Medicinal Plants-A compendium of 500 species (1994-1996) In still another embodiment of the present invention, the Vol. 3, p. 13, published by orient Longman, Chennai; Y. K. composition comprises 5-13 wt.% of powdered plant parts of Sarin in Illustrated lanual of herbal drugs used in Ayurveda Asparagus racemosus, 5-12 wt.% of powdered plant parts of (1996), p. 332, and The Ayurvedic Pharmacopoeia of India, p. Glycyrrhiza glabra, 8-14 wt.% of powdered plant parts of 50, published by Ministry of Health and Family Welfare, Sesamum indicum, 7-14 wt.% of powdered plant parts of India for the various medicinal properties of Ferula asafoe Musa sapientum, 4-12 wt.% of powdered plant parts of tida. Trachyspermum roxburghianum, 6-12 wt.% of powdered The composition of the present invention should not be plant parts of Aloe barbadensis, 5-12 wt.% of powdered plant treated as an obvious one as none of the citations are able to parts of Evolvulus alsinoides, 6-13 wt.% of powdered plant provide all the advantages of the present invention. 10 parts of Cyclea peltala, 9-14 wt.% of powdered plant parts of Embelia ribes, 7-14 wt.% of powdered plant parts of Cori OBJECTS OF THE INVENTION andrum sativum and 8-13 wt.% of plant parts of Ferula asafoetida, optionally along with one or more pharmaceuti The main object of the present invention is to provide a cally acceptable additives/carriers. This composition is here synergistic herbal composition for the treatment of gastric 15 after referred to as HF2. ulcer In one more embodiment of the present invention, the plant Yet another object of the present invention is to provide a part of Trachyspermum roxburghianum, Embelia ribes and process for the preparation of the composition. Coriandrum sativum is fruit. Still another object of the present invention is to provide a In one another embodiment of the present invention, the method for the treatment of gastric ulcer using the composi plant part of Cyclea peltata and Glycyrrhiza glabra is root. tion. In a further embodiment of the present invention, the plant part of Aloe barbadensis is elio. In a furthermore embodiment SUMMARY OF THE INVENTION of the present invention, the plant part of Asparagus racemo sus is tuber. The present invention provides a synergistic herbal com 25 In an embodiment of the present invention, the plant part of position for the treatment of gastric ulcer. Also, the present Sesamum indicum is seed. In another embodiment of the invention provides a process for the preparation of the com present invention, the plant part of Musa sapientum is unripe position. The present invention further provides a method for fruit. the treatment of gastric ulcer using said composition. In yet another embodiment of the present invention, the 30 plant part of Ferula asafoetida is resin. In accordance with the another embodiment of the present DETAILED DESCRIPTION OF THE PRESENT invention, there is provided a synergistic herbal composition INVENTION for the treatment of gastric ulcer, said composition compris ing equal proportions of 10 powdered plant parts selected In accordance with the first embodiment of the present 35 from the group comprising of powdered plant parts of invention, there is provided a synergistic herbal composition Asparagus racemosus, Glycyrrhiza glabra, Sesamum indi for the treatment of gastric ulcer, said composition essentially cum, Musa sapientum, Trachyspermum roxburghianum, comprising of powdered plant parts of Asparagus racemosus, Cyclea peltata, Embelia ribes, Coriandrum sativum, Ferula Glycyrrhiza glabra, Sesamum indicum, Musa sapientum and asafoetida, Aloe barbadensis and Evolvulus alsinoides, Trachyspermum roxburghianum and optionally, powdered 40 optionally along with one or more pharmaceutically accept plant parts of Cyclea peltata, Embelia ribes, Coriandrum able additives/carriers. sativum, Ferula asafoetida, Aloe barbadensis and Evolvulus In an embodiment of the present invention, said composi alsinoides along with one or more pharmaceutically accept tion comprises equal proportions of powdered plant parts of able additives/carriers. Asparagus racemosus, Glycyrrhiza glabra, Sesamum indi In an embodiment of the present invention, the composi 45 cum, Musa sapientum, Trachyspermum roxburghianum, tion comprises powdered plant parts of Asparagus racemo Cyclea peltata, Embelia ribes, Coriandrum sativum, Ferula sus, Glycyrrhiza glabra, Sesamum indicum, Musa sapientum asafoetida and Aloe barbadensis, optionally along with one and Trachyspermum roxburghianum in equal proportions, or more pharmaceutically acceptable additives/carriers. optionally along with one or more pharmaceutically accept In another embodiment of the present invention, said com able additives/carriers. This composition is hereafter referred 50 position comprises equal proportions of powdered plant parts to as HF3. of Asparagus racemosus, Glycyrrhiza glabra, Sesamum indi In another embodiment of the present invention, the com cum, Musa sapientum, Trachyspermum roxburghianum, position comprises powdered plant parts of Asparagus race Cyclea peltata, Embelia ribes, Coriandrum sativum, Ferula mosus, Glycyrrhiza glabra, Sesamum indicum, Musa sapien asafoetida and Evolvulus alsinoides, optionally along with tum, Trachyspermum roxburghianum, Evolvulus alsinoides 55 one or more pharmaceutically acceptable additives/carriers. and Ferula asafoetida in equal proportions, optionally along In yet another embodiment of the present invention, said with one or more pharmaceutically acceptable additives/car composition comprises equal proportions of powdered plant riers. This composition is hereafter referred to as HF4. parts of Asparagus racemosus, Glycyrrhiza glabra, Sesamum In yet another embodiment of the present invention, the indicum, Musa sapientum, Trachyspermum roxburghianum, composition comprises powdered plant parts of Asparagus 60 Cyclea peltata, Embelia ribes, Coriandrum sativum, Aloe racemosus, Glycyrrhiza glabra, Sesamum indicum, Musa barbadensis and Evolvulus alsinoides, optionally along with sapientum, Trachyspermum roxburghianum, Evolvulus alsi one or more pharmaceutically acceptable additives/carriers. noides, Ferula asafoetida, Coriandrum sativum, Cyclea In still another embodiment of the present invention, said peltata and Aloe barbadensis in equal proportions, optionally composition comprises equal proportions of powdered plant along with one or more pharmaceutically acceptable addi 65 parts of Asparagus racemosus, Glycyrrhiza glabra, Sesamum tives/carriers. This composition is hereafter referred. to as indicum, Musa sapientum, Trachyspermum roxburghianum, HF5. Cyclea peltata, Embelia ribes, Ferula asafoetida, Aloe bar US 7,651,705 B2 5 6 badensis and Evolvulus alsinoides, optionally along with one aforesaid plant parts in equal proportions to obtain a mixture or more pharmaceutically acceptable additives/carriers. and optionally adding one or more pharmaceutically accept In one more embodiment of the present invention, said able additives/carriers to the above mixture. composition comprises equal proportions of powdered plant In another embodiment of the present invention, said pro parts of Asparagus racemosus, Glycyrrhiza glabra, Sesamum cess comprises the steps of powdering plant parts of Aspara indicum, Musa sapientum, Trachyspermum roxburghianum, gus racemosus, Glycyrrhiza glabra, Sesamum indicum, Musa Cyclea peltata, Coriandrum sativum, Ferula asafoetida, Aloe sapientum, Trachyspermum roxburghianum, Evolvulus alsi barbadensis and Evolvulus alsinoides, optionally along with noides and Ferula asafoetida, mixing the aforesaid plant parts one or more pharmaceutically acceptable additives/carriers. in equal proportions to obtain a mixture and optionally adding In one another embodiment of the present invention, said 10 one or more pharmaceutically acceptable additives/carriers to composition comprises equal proportions of powdered plant the above mixture. parts of Asparagus racemosus, Glycyrrhiza glabra, Sesamum In yet another embodiment of the present invention, said indicum, Musa sapientum, Trachyspermum roxburghianum, process comprises steps of powdering plant parts of Aspara Embelia ribes, Coriandrum sativum, Ferula asafoetida, Aloe gus racemosus, Glycyrrhiza glabra, Sesamum indicum, Musa barbadensis and Evolvulus alsinoides, optionally along with 15 sapientum, Trachyspermum roxburghianum, Evolvulus alsi one or more pharmaceutically acceptable additives/carriers. noides, Ferula asafoetida, Coriandrum sativum, Cyclea In a further embodiment of the present invention, said peltata and Aloe barbadensis, mixing the aforesaid plant composition comprises equal proportions of powdered plant parts in equal proportions to obtain a mixture and optionally parts of Asparagus racemosus, Glycyrrhiza glabra, Sesamum adding one or more pharmaceutically acceptable additives/ indicum, Musa sapientum, Cyclea peltata, Embelia ribes, carriers to the above mixture. Coriandrum sativum, Ferula asafoetida, Aloe barbadensis In still another embodiment of the present invention, said and Evolvulus alsinoides, optionally along with one or more process comprises the steps of powdering and mixing 5-13 pharmaceutically acceptable additives/carriers. wt.% of plant parts of Asparagus racemosus, 5-12 wt.% of In a further more embodiment of the present invention, said plant parts of Glycyrrhiza glabra, 8-14 wt.% of plant parts of composition comprises equal proportions of powdered plant 25 Sesamum indicum, 7-14 wt.% of plant parts of Musa sapien parts of Asparagus racemosus, Glycyrrhiza glabra, Sesamum tum, 4-12 wt.% of plant parts of Trachyspermum rox indicum, Trachyspermum roxburghianum, Cyclea peltala, burghianum, 6-12 wt.% of plant parts of Aloe barbadensis, Embelia ribes, Coriandrum sativum, Ferula asafoetida, Aloe 5-12 wt.% of plant parts of Evolvulus alsinoides, 6-13 wt.% barbadensis and Evolvulus alsinoides, optionally along with of plant parts of Cyclea peltata 9-14 wt.% of plant parts of one or more pharmaceutically acceptable additives/carriers. 30 Embelia ribes, 7-14 wt.% of plant parts of Coriandrum In an embodiment of the present invention, said composi sativum and 8-13 wt.% of plant parts of Ferula asafoetida to tion comprises equal proportions of powdered plant parts of obtain a mixture and optionally adding one or more pharma Asparagus racemosus, Glycyrrhiza glabra, Musa sapientum, ceutically acceptable additives/carriers to the above mixture. Trachyspermum roxburghianum, Cyclea peltata, Embelia In one more embodiment of the present invention, the plant ribes, Coriandrum sativum, Ferula asafoetida, Aloe bar 35 part of Trachyspermum roxburghianum, Embelia ribes and badensis and Evolvulus alsinoides, optionally along with one or more pharmaceutically acceptable additives/carriers. Coriandrum sativum is fruit. In another embodiment of the present invention, said com In one another embodiment of the present invention, the position comprises equal proportions of powdered plant parts plant part of Cyclea peltata and Glycyrrhiza glabra is root. of Asparagus racemosus, Sesamum indicum, Musa sapien 40 In a further embodiment of the present invention, the plant tum, Trachyspermum roxburghianum, Cyclea peltata, Embe part of Aloe barbadensis is elio. In a furthermore embodiment lia ribes, Coriandrum sativum, Ferula asafoetida, Aloe bar of the present invention, the plant part of Asparagus racemo badensis and Evolvulus alsinoides, optionally along with one sus is tuber. or more pharmaceutically acceptable additives/carriers. In an embodiment of the present invention, the plant part of Sesamum indicum is seed. In another embodiment of the In yet another embodiment of the present invention, said 45 composition comprises equal proportions of powdered plant present invention, the plant part of Musa sapientum is unripe parts of Glycyrrhiza glabra, Sesamum indicum, Musa sapi fruit. entum, Trachyspermum roxburghianum, Cyclea peltata, In yet another embodiment of the present invention, the Embelia ribes, Coriandrum sativum, Ferula asafoetida, Aloe plant part of Ferula asafoetida is resin. barbadensis and Evolvulus alsinoides, optionally along with 50 In accordance with another object of the present invention, one or more pharmaceutically acceptable additives/carriers. there is provided a method of treating gastric ulcer in a Sub In accordance with the second embodiment of the present ject, said method comprising administering an effective invention, there is provided a process for the preparation of amount of the synergistic herbal composition essentially the synergistic herbal composition for the treatment of gastric comprising of powdered plant parts of Asparagus racemosus, ulcer, said process comprising the steps of powdering plant 55 Glycyrrhiza glabra, Sesamum indicum, Musa sapientum and parts essentially selected from Asparagus racemosus, Gly Trachyspermum roxburghianum and optionally, powdered cyrrhiza glabra, Sesamum indicum, Musa sapientum and plant parts of Cyclea peltata, Embelia ribes, Coriandrum Trachyspermum roxburghianum and optionally, selected sativum Ferula asafoetida, Aloe barbadensis and Evolvulus from Cyclea peltata, Embelia ribes, Coriandrum sativum alsinoides along with one or more pharmaceutically accept Ferula asafoetida, Aloe barbadensis and Evolvulus alsi 60 able additives/carriers. noides, mixing the aforesaid powdered plant parts to obtain a In an embodiment of the present invention, said method mixture and optionally adding one or more pharmaceutically comprises administering an effective amount of the synergis acceptable additives/carriers to the above mixture. tic herbal composition comprising of powdered plant parts of In an embodiment of the present invention, said process Asparagus racemosus, Glycyrrhiza glabra, Sesamum indi comprises the steps of powdering plant parts of Asparagus 65 cum, Musa sapientum and Trachyspermum roxburghianum in racemosus, Glycyrrhiza glabra, Sesamum indicum, Musa equal proportions, optionally along with one or more phar sapientum and Trachyspermum roxburghianum, mixing the maceutically acceptable additives/carriers. US 7,651,705 B2 7 8 In another embodiment of the present invention, said present invention and a standard drug "Omeprazole' against method comprises administering an an effective amount of Cold Restraint (at 4° C. temp, for 2 hrs.) induced Ulcer the synergistic herbal composition comprising of powdered (CRU). plant parts of Asparagus racemosus, Glycyrrhiza glabra, Table 2 represents the effect of the herbal composition HF2 Sesamum indicum, Musa sapientum, Trachyspermum rox prepared in accordance with one of the embodiments of the burghianum, Evolvulus alsinoides and Ferula asafoetida in equal proportions, optionally along with one or more phar present invention and the standard drug “Omeprazole' maceutically acceptable additives/carriers. against aspirin induced gastric ulcer. In yet another embodiment of the present invention, said Table 3 represents the effect of the herbal composition HF2 method comprises administering an effective amount of the prepared in accordance with one of the embodiments of the synergistic herbal composition comprising of powdered plant 10 present invention and the standard drug “Omeprazole' parts of Asparagus racemosus, Glycyrrhiza glabra, Sesamum against alcohol induced gastric ulcer in rats. indicum, Musa sapientum, Trachyspermum roxburghianum, Table 4 represents the effect of the herbal composition HF2 Evolvulus alsinoides, Ferula asafoetida, Coriandrum Sati prepared in accordance with one of the embodiments of the vum, Cyclea peltata and Aloe barbadensis in equal propor present invention and the standard drug “Omeprazole' tions, optionally along with one or more pharmaceutically 15 against Histamine induced ulcer model. acceptable additives/carriers. Table 5 represents the effect of the herbal composition HF2 In still another embodiment of the present invention, said prepared in accordance with one of the embodiments of the method comprises administering an effective amount of the present invention and a standard drug "Omeprazole' against synergistic herbal composition comprising 5-13 wt.% of Pyrolic ligation induced ulcer model. powdered plant parts of Asparagus racemosus, 5-12 wt.% of Table 6 gives the composition of the Herbal composition powdered plant parts of Glycyrrhiza glabra, 8-14 wt.% of powdered plant parts of Sesamum indicum, 7-14 wt.% of HF2 prepared in accordance with one of the embodiments of powdered plant parts of Musa sapientum, 4-12 wt.% of the present invention. powdered plant parts of Trachyspermum roxburghianum, Table 7 provides the antigastric ulcer activity of herbal 6-12 wt.% of powdered plant parts of Aloe barbadensis, 5-12 25 compositions HF3. HF4 and HF5 prepared in accordance wt.% of powdered plant parts of Evolvulus alsinoides, 6-13 with the embodiments of the present invention against cold wt.% of powdered plant parts of Cyclea peltata 9-14 wt.% of restrained ulcer model, pyloric ligation ulcer model and alco powdered plant parts of Embelia ribes, 7-14 wt.% of pow hol induced ulcer model. dered plant parts of Coriandrum sativum and 8-13 wt.% of Table 8 provides the results of the study conducted to plant parts of Ferula asafoetida in equal proportions, option 30 evaluate the synergistic effect of the composition HF2. ally along with one or more pharmaceutically acceptable Table 9 gives the composition of the Herbal compositions additives/carriers. HF3, HF4 and HF5. The invention is further described with In one more embodiment of the present invention, the respect to the following experiments which are given by way Subject is a mammal including human. of illustration and therefore should not be construed to limit In one another embodiment of the present invention, the 35 the scope of the invention in any manner. effective dosage of the composition per day is in the range of Experimental protocol: 5 to 15 g. Invivo experiments: In a further embodiment of the present invention, the com position can be in the form of tablets, capsules, syrup and any The Applicants have carried out several experiments under other conventional forms. different induced ulcer conditions and the effect of the herbal 40 In a furthermore embodiment of the present invention, the composition were studied and are tabulated herebelow. The composition is administered orally, intramuscularly, and by effect of the herbal composition has been compared with any other conventional methods. respect to a known anti-ulcer drug "Omeprazole'. In an embodiment of the present invention, the composi tion may be used for therapeutic as well as prophylactic EXPERIMENT 1: EFFECT ON COLD treatment of gastric ulcer. 45 RESTRAINT ULCERS (CRU) MODEL In another embodiment of the present invention, the subject may be administered a bolus dose or a multiple dose. METHOD: Adult rats of either sex, weighing 150-175 In yet another embodiment of the present invention, Gms were fasted for 24 hours with free access to water. The wherein the composition HF2 showed more than 62% pro test drugs were administered 45 minutes before immobilizing tection against cold restraint ulcer model. 50 the animals. The rats were immobilized in the restraint cage at In still another embodiment of the present invention, 4°C. in BOD incubator for 2 hrs and were sacrificed imme wherein the composition HF2 showed more than 30% pro diately after the restraint period. (According to the method of tection against aspirin induced ulcer model. Senay and Levine 1967). The abdomen was cut opened; stom In one more embodiment of the present invention, wherein ach was taken out and incised along the greater curvature to the composition HF2 reduced the length of hemorrhagic 55 observe the gastric lesions with the help of Magnascope bands to 22.67+4.69 (mmitSE) against alcohol induced gas (5xmagnification). tric ulcer. The following arbitrary scoring system was used to grade In one another embodiment of the present invention, the severity and intensity of the lesions. wherein the composition HF2 has protection index greater 1. Shedding of epithelium=10 than 80 against pyloric ligation induced ulcer. 60 2. Petechial and frank hemorrhages=20 3. One or two ulcers=30 BRIEF DESCRIPTION OF THE TABLES 4. More than two ulcers=40 5. Perforated ulcers=50 In the tables accompanying the specification, 65 The presence of any of these lesions was considered as a Table 1 represents the effect of the herbal composition HF2 positive ulcerogenic response which has been shown as per prepared in accordance with one of the embodiments of the centage of rats showing gastric lesions. US 7,651,705 B2 10 The severity of ulcers is expressed in terms of ulcer index, provides significantly better protection against cold restraint which is the mean score of gastric lesions of all the rats in a ulcer model as compared to Omeprazole. group which is defined as: Ulcer Index (U.I.)=Us+Upx10' Where Us=Mean severity of ulcer score and Up Percent EXPERIMENT 2: EFFECT ON ASPIRIN age of animals with Ulcer incidences INDUCED GASTRICULCER MODEL The percentage protection is calculated as follows: Percentage protection (C-T/C)x100. Wherein METHOD: Gastric ulceration was induced by aspirin C=Number of animals showing ulcer response in control 10 according to the method of Djahanguiri (1969). Aspirin (150 group and mp/Kg.) was administered per orally as a suspension in gum T-Number of animals showing ulcer response in test group. The effect of the Herbal Composition of the present inven acacia and the animal was sacrificed 5 hr. after the aspirin tion hereafter referred to as “HF2 against Cold Restraint treatment and the ulcer index with protection index were Ulcer Model (CRU) is given in Table 1. The effect of the 15 calculated. The results of the experiment is tabulated in Table standard drug “Omeprazole' is also given in Table 1. 2.

TABLE 1.

THE EFFECT OF THE HERBAL COMPOSITIONHF2 AND THE STANDARD DRUGOMEPRAZOLEAGAINST COLD RESTRAINTULCER MODEL (CRU). Ulcer severity Percentage of ulcer (type of lesions) incidence (No. of Compounds Scores (No. of rats showing Mean rats showing and lesions. No. of rats tested severity of ulcertotal No. of Ulcer Protection Doses 10 2O 30 40 50 ulcer score rats used) index index Control — 6/10 410 — — 24 100 (10/10) 12.4 OO CRU CRU - HF2 2,10 2f10 — — — O6 40 (4/10) 4.6 62.90 (50 mg. Kg, p...o.) CRU + Omeprazole 3/10 2/10 — — — O7 50 (5/10) 5.7 54.03 (10 mg. Kg, p.O.)

INFERENCE: Omeprazole showed 54.03% protection The effect of the herbal composition HF2 and the standard where as the composition HF2 showed 62.90%, protection drug "Omeprazole' against aspirin induced gastric ulcer is against gastric ulcer. Thus it is clear that the composition HF2 given in Table 2.

TABLE 2

THE EFFECT OF THE HERBAL COMPOSITIONHF2 AND THE STANDARD DRUGOMEPRAZOLE AGAINSTASPIRIN INDUCED GASTRICULCER

Percentage of Ulcer severity ulcer (type of lesions) Mean incidence Scores (No. of rats severity (No. of rats Compounds showing lesions. No. of showing and of rats tested) ulcer ulcertotal No. Ulcer Protection

Doses 10 20 30 40 SO Score of rats used) index index

Control — 26 46 — — 26.6 100 (6/6) 12.66 OO Aspirin (150 mg/KG, p.O.) Aspirin + HF 2 2.f6 2.6 — — — 10.0 66.7 (4/6) 7.67 39.41 (100 mg/Kg, p.O.) Aspirin + Omeprazole 2.f6 2.6 — — — 10.0 66.7 (4/6) 7.67 39.41 (10 mg. Kg, p.O.) US 7,651,705 B2 11 12 INFERENCE: Both Omeprazole and the composition HF2 mine administration. Histamine was administered in a dose of showed equal protection (39.41% protection) against aspirin 0.25 mg/Kg, i.m. at 30 minutes interval -for 7 times and it induced ulcer model. induced 100% duodenal ulceration in guinea pig (According to the method of Watt and Eagleton 1964). The animals were EXPERIMENT 3: EFFECT ON ALCOHOL sacrificed after half an hour of last injection under ether INDUCED GASTRICULCERS IN RATS anesthesia. The stomach along with duodenum was removed washed thoroughly and examined for the lesions and ulcer METHOD: Adult rats of either sex were taken; weighing index with protection index was calculated. The results of the 150-175 grams were fasted for 24 hours with fire access to experiment are tabulated in Table 4. The effect of the herbal water. The test drugs were administered (p.o.) 45 minutes 10 composition “HF2 and the standard drug “Omeprazole' before alcohol administration. 1 ml of chilled absolute alco against Histamine induced ulcer model is given in Table 4.

TABLE 4

THE EFFECT OF THE HERBAL COMPOSITIONHF2’ AND THE STANDARD DRUGOMEPRAZOLE AGAINST HISTAMINE INDUCED ULCERMODEL Ulcer severity (type Percentage of of lesions) Scores ulcer incidence (No. Guinea pig Mean (No. of animals showing lesions. No. of severity showing ulcer? Volume of Groups and doses of Guinea pig tested of ulcer total No. of gastric fluid compounds 10 20 30 40 SO score animals used) Ulcer index % Protection (mL) Ulcer Control Histamine — — 1.f3 2/3 — 36.6 100 (3/3) 13.66 OO 4.33 - 1.01 (0.25 mg/Kg, i.m.) x 7 Histamine + HF2 (50 mg/Kg, — — 1/3 – 10.0 33.3 (1/3) 4.33 68.3 16O. O.7 Histamine + Omeprazole — 1.f3 — 6.66 33.3 (1/3) 3.99 70.79 1.O. O.2 (10 mg/kg, p.o.) hol was amine (p.o.) to the rats (According to Wittetal). INFERENCE: In this model, Omeprazole showed 70.79% Immediately after 1 hour, the animals were anesthetized, protection whereas the composition HF2 showed 68.3% pro abdomen was cut opened stomach was taken out and incised tection. In comparison, the composition HF2 provides more along the greater curvature to observe the gastric lesions. The 35 or less equal protection. ulcers are examined under the 5X magnification with the help of magnascope. Absolute ethanol lesions appears as blackish EXPERIMENTS 5: EFFECT ON PYLORIC lesions grouped in patches of varying size, usually parallel to LIGATION INDUCED ULCER MODEL the major axis of the stomach. The lengths of the lesions are measured and Summated to give a total lesion score, then 40 METHOD: Animals were fasted for 24 hours in the raised calculated and expressed in percentage. mesh bottom cages to prevent coprophagia and were allowed The effect of the herbal composition “HF2 and the stan free access to water. The control group of rats was feed with dard drug "Omeprazole' against alcohol induced gastric the vehicle and the experimental groups with their respective ulcer in rats is given in Table 3. drugs 45 minutes prior to the ligation. The animal was anes 45 thetized, abdomen was cut opened under Xiphoid process, and TABLE 3 the pyloric portion of the stomach was slightly liked and ligated avoiding any damage to the adjacent blood vessels THE EFFECT OF THE HERBAL COMPOSITIONHF2 AND THE STANDARD DRUGOMEPRAZOLEAGAINST (According to the method of Shay et al. 1945). The animals ALCOHOL INDUCED GASTRICULCER INRATS were stitched and kept for 4 hours with free access to water. 50 After 4 hours the animals were sacrificed under ether anes Length of hemorrhagic thesia and the stomach was dissected out incised along the Compound bands (mm + SE) greater curvature. The stomach was washed thoroughly and Ethanol control 73.5 - 1.5 the ulcer index was scored as per in other ulcer models. The HF 2 (100 mg/kg, p.o.) + Ethanol 22.67 +4.69 results of the experiment are tabulated in Table 5. Omeprazole (100 mg/kg, p.o.) + 56.0 9.12 55 The effect of the herbal composition “HF2’ and the stan Ethanol dard drug “Omeprazole' against Pyloric ligation induced ulcer model is given in Table 5. INFERENCE: The composition of the present invention showed significant protection against this model also. The TABLE 5 protection provided by the composition of the present inven 60 tion is better than Omeprazole. EFFECT OF OMEPRAZOLE AND THE HERBAL COMPOSITION HF2AGAINST PYLORIC LIGATION INDUCED ULCER EXPERIMENT 4: EFFECT ON HISTAMINE INDUCED ULCER MODEL Groups Ulcer Index Protection Index 65 Ligation Control 16.6 O.O METHOD: Animals were fasted for 24 hours with access Ligation + HF2 1.65 84.08 to water. The drug was given orally 1 hour prior to the hista US 7,651,705 B2 13 14

TABLE 5-continued TABLE 7

ANTIGASTRICULCERACTIVITY OF THE HERBAL EFFECT OF OMEPRAZOLE AND THE HERBAL COMPOSITION COMPOSITIONSHF3. HF4AND HFS HF2AGAINST PYLORIC LIGATION INDUCED ULCER Cold restrained Pyloric ligation Alcohol induced Formulation ulcer model model ulcer model Groups Ulcer Index Protection Index HF3 66.69 41.75 86.54 Ligation + Omeprazofe 6.6 51.44 HF4 45.86 17.0 79.42 (10 mg/Kg, p.o.) 10 HFS 45.86 62.75 85.75 In order to conduct a study on the Synergistic effect, the INFERENCE: The composition of the present invention herbal composition HF2 was taken and each component was removed and the effect of the resultant composition against showed better protection than Omeprazole in the pyloric liga 15 tion induced ulcer model. cold restrained gastric ulcer model was studied. The results of the experiment thus conducted is tabulated in Table 8. It was concluded from the above experiments that the batch pre EXPERIMENT 6: EFFECT OF THE PRESENT pared by the removal of Emblica ribes has shown very good COMPOSITION ON ACETYLCHOLINE AND protection. HISTAMINE INDUCED CONTRACTION OF GUINEA-PIGILEUM TABLE 8 METHOD: A piece of 2-3 cm of the terminal ileum of a RESULTS OF THE SYNERGISTICEFFECT STUDY freshly killed Guinea pig was ended in an organ bath contain 25 S. No. Details of Batch Ulcer Index ing Tyrode solution at 34° C. and bubbled with fresh air. 1 HF2 without Aloe barbadensis 26.6 Contraction was induced by Submaximal contraction of ace 2 HF2 without Asperagiis racemosus 11.6 tylcholine chloride (1 ig/mL) and Histamine (1 ng/mL) and 3 HF2 without Glycyrrhiza glabra 1S.O 4 HF2 without Seamum indicum 2O.O it was recorded on a kymograph (According to the method of 5 HF2 without Evolvulus aisinoides 13.3 Patnaik 1992). The composition HF2 (up to 250 ng/mL) did 30 6 HF2 without Trachyspermum oxhunghianum 2O.O 7 HF2 without Empeica ribes 8.3 not exert any significant influence on isolated tissue prepara 8 HF2 without Coriandrum Saiivum 1.O.O tion for anticholinergic (acetylcholine-induced contraction of 9 HF2 without Cyclea peltata 11.66 Guinea-pig ileum) and Fk-anti-histaminic (Histamine 10 HF2 without Ferula asafetida 13.0 11 HF2 without Musa sapientum 2O.O induced contraction of Guinea-pig ileum) activity. 35 EXPERIMENT 7: HERBS AND PREPARATION OF THE COMPOSITION TABLE 9 COMPOSITION OF THE HERBAL COMPOSITIONS HF3, For the purpose of conducting animal experiment all the 40 HF4 AND HFS herbs are washed dried and pulverised. All the herbs are taken HF3 HF4 HFS in the proportion as shown in Table 6. The whole mixture is 1. Asperagus 1. Asperagus 1. Asperagus blended well and used for administering. *GeicStiS FCeicStiS *GeicSiS The components and their proportions of the standard 45 2. Glycyrrhiza glabra 2. Glycyrrhiza glabra 2. Glycyrrhiza glabra 3. Seaanum indicum 3. Seaanum indicum 3. Seaamim indicum herbal composition according to one embodiment of the 4. Mitsa sapientain 4. Mitsa sapientain 4. Mitsa sapientain present invention are listed in Table 6. The part of the herb and 5. Trachyaparmum 5. Trachyaparmum 5. Trachyaparmum which is used is also mentioned. The placebo preparation is roxburghicinum roxburghicinum roxburghicinum designed to taste, Smell and look like an Ayurvedic herbal All in equal 6. Evolvulus aisinodes 6. Evolvulus alsinodes composition. 50 proportions and 7. Ferula asafoetida 7. Ferula asafoetida All in equal 8. Coriandrum sativum TABLE 6 proportions 9. Cyclea peitate and 10. Aloe barbadensis THE COMPOSITION OF THE HERBAL COMPOSITIONHF2 All in equal proportions 55 S.No. Name of the plant and its part used Percentage 1. Aloe barbadensis (elio) 6-12% The invention claimed is: 2. Asperagiis racemosus (Tubers) S-13% 1. A herbal composition for the treatment of gastric ulcer, 3. Glycyrrhiza glabra (roots) 5-12% said composition comprising a powdered plant part of a plant 4. Seaamium indicum (seeds) 8-14% 5. Evolvulus aisinodes (whole plant) 5-12% 60 selected from the group consisting of Aparagus racemousus, 6. Musa Sapientiim (unripe fruit) 7-14% Glycrrhiza glabra, Sesamum indicum, Musa sapientum, Tra 7. Trachyaparmum roxburghicinum (fruits) 4-12% chyspermum roxburghianum, Cyclea peltata, Embelia ribes, 8. Embelia ribes (fruits) 9-14% Coriandrum sativum, Aloe barbadensis and Evolvulus alsi 9 Coriandrum sativum (fruits) 7-14% 10. Cycleapeitate (root) 6-1.3% noides, a resin from Ferula asafoetida and one or more phar 11 Fertila asafoetida (resin) 8-1390 65 maceutically acceptable additives or carriers, wherein said composition comprises each of Asparagus racemosus, Gly cyrrhiza glabra, Sesamum indicum, Musa sapientum and US 7,651,705 B2 15 16 Trachyspermum roxburghianum in about equal proportions vum, Cyclea peltata and Aloe barbadensis in equal propor by weight and Such about equal proportion has a value greater tions by weight, and one or more pharmaceutically acceptable than Zero. additives or carriers. 4. The composition as claimed in claim 1, wherein the plant 2. The composition as claimed in claim 1, wherein the part of each of Embelia ribes and Coriandrum sativum is a composition comprises a powdered plant part of each of fruit. Asparagus racemosus, Glycyrrhiza glabra, Sesamum indi 5. The composition as claimed in claim 1, wherein the plant cum, Musa sapientum and Trachyspermum roxburghianum in part of Cyclea peltata and Glycyrrhiza glabra is a root. equal proportions by weight, and one or more pharmaceuti 6. The composition as claimed in claim 1, wherein the plant cally acceptable additives or carriers. part of Asparagus racemosus is a tuber. 3. The composition as claimed in claim 1, wherein the 7. The composition as claimed in claim 1, wherein the plant composition comprises a powdered plant part of each of part of Sesamum indicum is a seed. Asparagus racemosus, Glycyrrhiza glabra, Sesamum indi 8. The composition as claimed in claim 1, wherein the plant cum, Musa sapientum, Trachyspermum roxburghianum, part of Musa sapientum is an unripe fruit. Evolvulus alsinoides, Ferula asafoetida, Coriandrum Sati k k k k k